Barcelona consensus on biomarker-based immunosuppressive drugs management in solid organ transplantation

Abstract: With current treatment regimens, a relatively high proportion of transplant recipients experience underimmunosuppression or overimmunosuppression. Recently, several promising biomarkers have been identified for determining patient alloreactivity, which help in assessing the risk of rejecti...

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Hauptverfasser: Brunet, Mercè (VerfasserIn) , Sommerer, Claudia (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: April 2016
In: Therapeutic drug monitoring
Year: 2016, Jahrgang: 38, Pages: 1-20
ISSN:1536-3694
DOI:10.1097/FTD.0000000000000287
Online-Zugang:Verlag, Volltext: https://doi.org/10.1097/FTD.0000000000000287
Verlag, Volltext: https://journals.lww.com/drug-monitoring/fulltext/2016/04001/Barcelona_Consensus_on_Biomarker_Based.1.aspx#pdf-link
Volltext
Verfasserangaben:Mercè Brunet, Maria Shipkova, Teun van Gelder, Eberhard Wieland, Claudia Sommerer, Klemens Budde, Vincent Haufroid, Uwe Christians, Marcos López-Hoyos, Markus J. Barten, Stein Bergan, Nicolas Picard, Olga Millán López, Pierre Marquet, Dennis A. Hesselink, Ofelia Noceti, Tomasz Pawinski, Pierre Wallemacq, and Michael Oellerich

MARC

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520 |a Abstract: With current treatment regimens, a relatively high proportion of transplant recipients experience underimmunosuppression or overimmunosuppression. Recently, several promising biomarkers have been identified for determining patient alloreactivity, which help in assessing the risk of rejection and personal response to the drug; others correlate with graft dysfunction and clinical outcome, offering a realistic opportunity for personalized immunosuppression. This consensus document aims to help tailor immunosuppression to the needs of the individual patient. It examines current knowledge on biomarkers associated with patient risk stratification and immunosuppression requirements that have been generally accepted as promising. It is based on a comprehensive review of the literature and the expert opinion of the Biomarker Working Group of the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. The quality of evidence was systematically weighted, and the strength of recommendations was rated according to the GRADE system. Three types of biomarkers are discussed: (1) those associated with the risk of rejection (alloreactivity/tolerance), (2) those reflecting individual response to immunosuppressants, and (3) those associated with graft dysfunction. Analytical aspects of biomarker measurement and novel pharmacokinetic-pharmacodynamic models accessible to the transplant community are also addressed. Conventional pharmacokinetic biomarkers may be used in combination with those discussed in this article to achieve better outcomes and improve long-term graft survival. Our group of experts has made recommendations for the most appropriate analysis of a proposed panel of preliminary biomarkers, most of which are currently under clinical evaluation in ongoing multicentre clinical trials. A section of Next Steps was also included, in which the Expert Committee is committed to sharing this knowledge with the Transplant Community in the form of triennial updates. 
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